Plain English Summary

Background and study aims Cerebral palsy is a term that is used to describe a number of neurological conditions resulting in problems with movement and co-ordination. It is caused by damage to the part of the brain before, during or just after birth that is responsible for motor control (muscles that control movement). We want to see if a widely available home console system (the Nintendo Wii Fit) can be used to provide regular, tailored physiotherapy, or virtual reality therapy (VRT), to children with cerebral palsy.

Who can participate? Children aged 5-16 with cerebral palsy that are able to walk and are managed by the Sussex Community NHS Trust, and their families.

What does the study involve? The children are randomly allocated into one of two groups. Those in group 1 (the intervention group) follow a therapist prescribed schedule for 12 weeks, playing with specified Nintendo Wii Fit games for a specified amount of time per session. Each session lasts 30 minutes and take place three times a week. The games are chosen based on specific physiotherapy purposes, such as core stability or balance. During this 12 week period, the family is contacted every two weeks to see how the child is progressing, make changes to the games played as necessary and answer any questions that the family may have. Those in group 2 (control group) also play with the Nintendo Wii Fit console 3 times a week in 30 minute sessions, but they are able to choose whatever games they like. The family is not contacted at all during the 12 weeks, unless they need physiotherapy advice. All participants, including the parents, are asked to keep a simple daily diary to rate sessions. The children’s balance and mobility is tested just before they start the trial, half way though and then at the end. All participants are also asked to fill in a questionnaire after the trial has ended (an exit questionnaire) in which they can report on engagement, ease of use and tiredness after sessions.

What are the possible benefits and risks of participating? Not provided at time of registration

Where is the study run from? Nightingale Primary Care Centre (UK)

When is the study starting and how long is it expected to run for? February 2015 to January 2016

ORCID ID

Contact details

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

18271

Study information

Scientific title

A feasibility study of virtual reality as a therapeutic intervention in children with ambulatory cerebral palsy

Acronym

CPWiiO

Study hypothesis

1. What does the current use of commercially available systems in the home look like, and therefore, how different would a prescribed programme be?2. If virtual reality therapy (VRT) is effective, is it the amount or type of activity? A comparison of usage of home-based systems will be undertaken to question whether it is the amount of play time or scaffolded practice that contributes to therapeutic effects and whether childrens enjoyment influences engagement and participation. Amount of contact with children, families and professionals will also be logged to analyse economic impact of either wing of the study (supported, unsupported use).3. Which tools are primary measuring devices that produce consistent and reliable results with VRT? Standardised balance and mobility measures alongside child-defined goals will consider benefits of Nintendo Wii fit on individual functionally meaningful outcomes.

Ethics approval

Lancaster NRES committee, 02/12/2014, ref: 14/NW/1499

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet

Condition

Cerebral Palsy

Intervention

1. Control Group:Control participants will use the Nintendo Wii Fit for 30-minute sessions, 3 times a week, over a 12-week period. They will have free choice over which games they choose and duration each game is played within the session. Scheduled phone contact will be made every two weeks but only to oversee progress or if they need physiotherapy advice2. Supported Group:Supported participants will follow a therapist prescribed schedule over a 12-week period, utilising specified Nintendo Wii Fit games for designated amounts of time per session. Sessions will last 30 minutes, undertaken three times a week with games selected for specific physiotherapy purposes, such as core stability or balance. During this 12-week period, fortnightly telephone contact to families will oversee the child’s progress, update game selection and respond to any queries.

Primary outcome measure

Measurements will be taken at baseline (week 1), midway (week 6), and exit of trial period (week 12). Measurements will be taken by blinded members of the trial team.

Secondary outcome measures

N/A

Overall trial start date

01/12/2014

Overall trial end date

01/01/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Inclusion criteria for questionnaire (phase one of study):1.1. Parents of children with cerebral palsy of any level (ie GMFCS 1-5)1.2. Child aged 5 to 16 years old1.3. Under management of Sussex Community NHS Trust identified from local clinical database

2. Inclusion criteria for randomised, single blind, controlled study (phase two of study):2.1. Ambulatory Bilateral and Unilateral CP2.2. GMFCS types I and II e.g. able to walk without a walking aid2.3. Ability to follow simple task instruction2.4. All school ages -from 5 up to the age of 16; primary -5 to 11 years and secondary >11 – 16 years, (Upper limit of 16 to avoid timetabling variations at 6th form programmes)2.5. Under management of Sussex Community NHS Trust, identified from local clinical database

Participant type

Age group

Gender

Target number of participants

Participant exclusion criteria

1. Exclusion criteria for questionnaire (phase one of study):1.1. Child aged less than 5 or over 16 years old

2. Exclusion criteria for randomised, single blind, controlled study (phase two of study):2.1. Children who are GMFCS III, IV, V2.2. Child/Family unable to follow simple task instructions in English2.3. Over the age of 16, outside of school age2.4. Child with epilepsy who is photosensitive and has had a seizure within the last year2.5. On anticonvulsant medication

Sponsor information

Organisation

Sponsor details

Research and Development Freshfield Annex Brighton General Hospital Elm Grove Brighton BN2 3EW United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Dissemination to national conferences e.g. BACD, RCPCH, study applications to Journal of Developmental Medicine and Child Neurology, human computer interaction journals and conferences (e.g. TEI, CHI, UBICOMP) Publication of phase 1 date autumn 2015 phase 2 publication data to be published late 2016 Further theory papers to be written and published where the opportunity arises.

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

29/05/2018: The recruitment start date was corrected from 05/02/2015 to 27/07/2015.
24/05/2016: Added name of ethics committee.
23/05/2016: Changed recruitment end date from 31/07/2016 to 10/05/2016.